{
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0638-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Trilogy Evo and Trilogy Evo O2  Material Numbers BL2110X15B  BR2110X18B  CA2110X12B  DE2100X13B  DE2110X13B  DS2100X11B  DS2110X11B  EE2100X15B  EE2110X15B  ES2100X15B  ES2110X15B  EU2100X15B  EU2100X19  EU2110X15B  FR2100X14B  FR2110X14B  FX2100X15B  GB2110X15B  IA2100X15B  IA2110X15B  IN2100X15B  IN2100X19  IN2110X15B  IT2100X21B  IT2110X21B  JP2100X16B  JP2110X16B  KR2110X15B  LA2100X15B  LA2110X15B  ND2110X15B  RDE2100X13B  RDE2110X13B  RDS2110X11B  RIN2100X15B  RIN2110X15B  RJP2100X16B  RJP2110X16B  UDS2110X11B",
  "description": "FDA recall Z-0638-2024 — Philips Respironics, Inc. is recalling Trilogy Evo and Trilogy Evo O2  Material Numbers BL2110X15B  BR2110X18B  CA2110X12B  DE2100X13B  DE2110X13B  DS2100X11B  DS2110X11B  EE2100X15B  EE2110X15B  ES2100X15B  ES2110X15B  EU2100X15B  EU2100X19  EU2110X15B  FR2100X14B  FR2110X14B  FX2100X15B  GB2110X15B  IA2100X15B  IA2110X15B  IN2100X15B  IN2100X19  IN2110X15B  IT2100X21B  IT2110X21B  JP2100X16B  JP2110X16B  KR2110X15B  LA2100X15B  LA2110X15B  ND2110X15B  RDE2100X13B  RDE2110X13B  RDS2110X11B  RIN2100X15B  RIN2110X15B  RJP2100X16B  RJP2110X16B  UDS2110X11B (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
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  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
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  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0638-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Trilogy Evo and Trilogy Evo O2  Material Numbers BL2110X15B  BR2110X18B  CA2110X12B  DE2100X13B  DE2110X13B  DS2100X11B  DS2110X11B  EE2100X15B  EE2110X15B  ES2100X15B  ES2110X15B  EU2100X15B  EU2100X19  EU2110X15B  FR2100X14B  FR2110X14B  FX2100X15B  GB2110X15B  IA2100X15B  IA2110X15B  IN2100X15B  IN2100X19  IN2110X15B  IT2100X21B  IT2110X21B  JP2100X16B  JP2110X16B  KR2110X15B  LA2100X15B  LA2110X15B  ND2110X15B  RDE2100X13B  RDE2110X13B  RDS2110X11B  RIN2100X15B  RIN2110X15B  RJP2100X16B  RJP2110X16B  UDS2110X11B",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Philips Respironics, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0638-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0638-2024: Philips Respironics, Inc. is recalling Trilogy Evo and Trilogy Evo O2  Material Numbers BL2110X15B  BR2110X18B  CA2110X12B  DE2100X13B  DE2110X13B  DS2100X11B  DS2110X11B  EE2100X15B  EE2110X15B  ES2100X15B  ES2110X15B  EU2100X15B  EU2100X19  EU2110X15B  FR2100X14B  FR2110X14B  FX2100X15B  GB2110X15B  IA2100X15B  IA2110X15B  IN2100X15B  IN2100X19  IN2110X15B  IT2100X21B  IT2110X21B  JP2100X16B  JP2110X16B  KR2110X15B  LA2100X15B  LA2110X15B  ND2110X15B  RDE2100X13B  RDE2110X13B  RDS2110X11B  RIN2100X15B  RIN2110X15B  RJP2100X16B  RJP2110X16B  UDS2110X11B",
      "text": "The FDA logged enforcement record Z-0638-2024: Philips Respironics, Inc. is voluntarily recalling Trilogy Evo and Trilogy Evo O2  Material Numbers BL2110X15B  BR2110X18B  CA2110X12B  DE2100X13B  DE2110X13B  DS2100X11B  DS2110X11B  EE2100X15B  EE2110X15B  ES2100X15B  ES2110X15B  EU2100X15B  EU2100X19  EU2110X15B  FR2100X14B  FR2110X14B  FX2100X15B  GB2110X15B  IA2100X15B  IA2110X15B  IN2100X15B  IN2100X19  IN2110X15B  IT2100X21B  IT2110X21B  JP2100X16B  JP2110X16B  KR2110X15B  LA2100X15B  LA2110X15B  ND2110X15B  RDE2100X13B  RDE2110X13B  RDS2110X11B  RIN2100X15B  RIN2110X15B  RJP2100X16B  RJP2110X16B  UDS2110X11B — reason: The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg.   The AVAPS feature is contraindicated for patients less than 10 kg.    Potential harms if devices are used on contraindicated patients include barotrauma, hypoventilation/hypercapnia, and rebreathing of excessive CO2.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-11-27. Affected lots/codes: Material   UDI-DI/GTIN BL2110X15B 606959055520 BR2110X18B 606959055476 CA2110X12B 606959052307 DE2100X13B 606959054103 DE2110X13B 606959054110 DS2100X11B 606959051997 DS2110X11B 606959051942 EE2100X15B 606959055698 EE2110X15B 606959055544 ES2100X15B 606959054097 ES2110X15B 606959054080 EU2100X15B 606959055674 EU2100X19 606959055681 EU2110X15B 606959054981 FR2100X14B 606959055643 FR2110X14B 606959055506 FX2100X15B 606959061019 GB2110X15B 606959054127 IA2100X15B 606959055636 IA2110X15B 606959055490 IN2100X15B 606959054059 IN2100X19 606959055575 IN2110X15B 606959051959 IT2100X21B 606959055438 IT2110X21B 606959055421 JP2100X16B 606959055582 JP2110X16B 606959051973 KR2110X15B 606959055483 LA2100X15B 606959055599 LA2110X15B 606959055452 ND2110X15B 606959055513 RDE2100X13B  RDE2110X13B  RDS2110X11B 606959060517 RIN2100X15B  RIN2110X15B  RJP2100X16B  RJP2110X16B  UDS2110X11B 606959060500  All units of listed models are affected by this correction.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "SourceCitation",
        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0638-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0638-2024&lang=eng"
        }
      },
      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0638-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0638-2024 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0638-2024&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0638-2024&lang=eng"
        }
      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0638-2024/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
    }
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      "name": "FDA recall details — Z-0638-2024",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0638-2024",
            "Status": "recorded"
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          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
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        {
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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        {
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Philips Respironics, Inc.",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg.   The AVAPS feature is contraindicated for patients less than 10 kg.    Potential harms if devices are used on contraindicated patients include barotrauma, hypoventilation/hypercapnia, and rebreathing of excessive CO2.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-11-27",
            "Status": "recorded"
          }
        },
        {
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Material   UDI-DI/GTIN BL2110X15B 606959055520 BR2110X18B 606959055476 CA2110X12B 606959052307 DE2100X13B 606959054103 DE2110X13B 606959054110 DS2100X11B 606959051997 DS2110X11B 606959051942 EE2100X15B 606959055698 EE2110X15B 606959055544 ES2100X15B 606959054097 ES2110X15B 606959054080 EU2100X15B 606959055674 EU2100X19 606959055681 EU2110X15B 606959054981 FR2100X14B 606959055643 FR2110X14B 606959055506 FX2100X15B 606959061019 GB2110X15B 606959054127 IA2100X15B 606959055636 IA2110X15B 606959055490 IN2100X15B 606959054059 IN2100X19 606959055575 IN2110X15B 606959051959 IT2100X21B 606959055438 IT2110X21B 606959055421 JP2100X16B 606959055582 JP2110X16B 606959051973 KR2110X15B 606959055483 LA2100X15B 606959055599 LA2110X15B 606959055452 ND2110X15B 606959055513 RDE2100X13B  RDE2110X13B  RDS2110X11B 606959060517 RIN2100X15B  RIN2110X15B  RJP2100X16B  RJP2110X16B  UDS2110X11B 606959060500  All units of listed models are affected by this correction.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution: US (nationwide)-AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Including PR; and OUS (International) including countries of: AE, AR,AT, AU, BD, BE, BG, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, ;EC EE, EG, ES, FI, FR, GB, GE, GF, GR, GT, HK, HR, HU, IE, IL, IN, IT, JO, JP, KE, KR, KW, LB, LT, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, OM, PA, PE, PF, PH, PK, PL, PR, PT, PY, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, YT, ZA and ZW.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}